When the going gets tough, get a woman

64 women to sue in 3 Japanese courts over health woes from cervical cancer vaccines

A group of lawyers for 64 women who are suffering health problems from cervical cancer vaccines said Tuesday the victims will file damages lawsuits against the government and two drug makers that produced the vaccines through four district courts on July 27.

Of the 64 women, 28 will lodge their suit with the Tokyo District Court, six with the Nagoya District Court, 16 with the Osaka District Court and 14 with the Fukuoka District Court, according to the lawyers.

Initially, the victims, mainly teenagers, will demand ¥15 million in damages each, for a total of ¥960 million, and increase the amount later depending on their symptoms. The victims’ health problems include pain all over the body.

The average age of the 28 planning to file their suit with the Tokyo court is 18. They received the vaccination when they were between 11 and 16 years old.

Noting that the cervical cancer vaccines have caused nerve disorders and other problems due to the excessive immune reactions they caused, the lawyers claimed that the government’s approval of the ineffective vaccines was illegal. The drug makers bear product liability, they added.

Masumi Minaguchi, one of the lawyers, said, “We aim to clarify the responsibilities of the government and the drug makers through the lawsuits so that the victims can live without anxiety:’

Cervical cancer vaccines were included in routine vaccination programs in April 2013. But the government stopped its recommendations for the use of the vaccines in June the same year after receiving reports on complaints of health damage.

Meanwhile, the Japan Pediatric Society and 16 other institutions in April recommended active use of the vaccines, saying it is clear they are effective in preventing cervical cancer.

The organization behind this action is MedWatcher Japan, who have been one of the most effective organizations in the world at holding Pharma to account. Two of their key players Masumi Minaguchi and Hiro Bepu are seen here. Masumi Minaguchi is the lawyer taking this case.

In this case MedWatcher have capitalized on the fact the HPV Vaccine is given primarily to girls and women who are old enough to be able to complain when things go wrong afterwards.

The science behind the MedWatcher case is presented in their refutation of the Global Advisory Committee on Vaccine Safety position which can be accessed HERE.

The HPV vaccines look like being a problem for vaccine advocates in that they puncture the claim that vaccines are safe and the only risks stem from not giving them.

Earlier this year Merck admitted their Shingles vaccine could cause eye damage. Again the difference is that the people suffering the harm are old enough to make their voices heard.

The response from vaccine advocates in the case of HPV vaccines has been to push for giving these vaccines in infancy.

Vaccines are a conundrum. They can clearly be effective and most of us would want to avail of most of them. But where elsewhere in medicine, it is legitimate to be against over-medicalization, being against over-vaccination puts anyone who advocates it beyond the pale.

Why?

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“The decision to immunise girls as young as 12–13 years has caused much controversy. Given that the virus is only transmitted through sex, some parents felt uneasy that their children had to be immunised at such low age. Adding to this are the fears generated by adverse reactions caused by the vaccine in younger children. According to a report released by the UK government in March 2009, the vaccine caused 1,340 instances of adverse reactions such as nausea, convulsions, fatigue, fever, vomiting, diarrhoea, paraesthesia and myalgia (muscular pains).

However, the UK government has defended the decision, with the Medicines and Healthcare products Regulatory Agency (MHRA) announcing that most of the adverse reactions were in line with expectations and were due to recognised side effects.
The Department of Health and MHRA started the immunisation programme for 12–13-year-old girls in September 2008 and the vaccine will be offered to 17–18-year-old girls during 2010.

GSK’s China unit said in a statement Cervarix will be the first HPV vaccine licensed for use in the country and is expected to be launched there in early 2017.

GSK has had a rough ride in China. It has struggled to rebuild sales after being fined nearly $500 million in 2014 for bribing doctors in the country. In May, Chinese health authorities sharply cut the prices of three drugs, including GSK’s hepatitis B drug Viread.

Dr Tom Jefferson is one of the authors of this complaint to the EMA, which acknowledges that “aluminium adjuvant is neurotoxic in high doses”.

However, previously, Tom Jefferson has defended the use of aluminium in vaccines, and downplayed the risks. In 2004, The Lancet Infectious Diseases journal published a review by Tom Jefferson et al of the Cochrane Vaccines Field in which they stated: “We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events. Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.”[1]

In their review Jefferson et al admitted that “Overall, the methodological quality of included studies was low”. And yet “despite a lack of good-quality evidence” Jefferson et al advised “we do not recommend that any further research on this topic is undertaken”.

Is this not bizarre? I challenged Tom Jefferson about this, and also wrote to the Editor of The Lancet Infectious Diseases requesting that Jefferson et al’s poorly evidenced review be retracted. I received no response.

I suggest Jefferson et al’s 2004 review on aluminium and vaccine safety facilitated poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines, and the result is the burgeoning number of aluminium-adjuvanted vaccines and revaccinations we are seeing today.

When is Jefferson going to address the fallout of his 2004 review, which he admits was based on studies of low methodological quality?

It is a very great conundrum: it seems like commonsense but it also turns the basic medical principle of medical ethics “First do no harm” on its head. In some cases the principle of not doing harm can be violated in absurd ways (for instance, with the nasal flu vaccine which actually puts the unvaccinated population at risk by uncontrolled shedding while being largely useless at preventing the disease). If preventing harm was really the fundamental motivation of of the program (as opposed to making loads of money out of a captive market) why would such a product be licensed and added to the schedule?

Another basic issue, which I highlighted in these columns is the repressive measures (which occur at various institutional levels) to prevent real harm ever being publicly discussed. If vaccines were that good, what would be the problem?

Or we could consider the hundreds of millions of vaccine products that have been issued and administered in the UK since 2010 without a single case of injury ever having been compensated (as far as I know) amid all but complete suppression of public discussion. We have an incredible machine for asserting the benefits and denying the harms (and most particularly for trashing anyone dares ever to speak up). Although vaccines are not scrutinised very carefully, we still have pretty good idea that in many cases they are not that effective, and not that safe.

My own view is that if this is going to be any kind proper public policy it should be done more carefully, later (in the case of small children), and less – while victims and critics have to be listened to respectfully. The vast hostility which is unleashed on anyone who speaks up in itself skews any scientific base for the safety of product and may also give the impression that they are much more effective than in reality (for one thing doctors stop diagnosing the disease). I remember a Nuffield consultation on bioethecs a decade ago which made the claim that vaccines had eradicated whooping cough, which was not at all the case (it was just nobody diagnosed it because they were not looking) and it is also very dangerous vaccine. The JCVI and the DH long ago buried the evidence and this awful story was reported by Bill Inman (founder of the UK Yellow Card Scheme) in his book ‘Don’t tell the patient’. But in 1990, a decade and a half after the problem was discovered, they deliberately stepped up the risk by intensifying the program with an accelerated schedule.

Do we want “most” vaccines? If you look at the US and UK schedules for infants and young children, they are bulging: the ACIP and the JCVI scarcely know how to fit any more in, but many more are on their way. Vaccines are being proposed as an answer to antibiotic overload but we have no test basis for believing the present schedule is sustainable, let alone a further greatly expanded one to combat other forms of institutional/industrial lassitude.

The question is “How do we prevent disease?” and I think we have probably vastly over-estimated the role of such products. I don’t think Tom Jefferson has been above reproach in this saga but I also think of his comment when Der Spiegel quizzed him about what he would do about the swine flu virus in 2009, and he remarked that he washed his hands rather a lot. The primary elements in controlling disease are clean water, sanitation, good nutrition, decent housing.

Vaccines, if and when they work do so by artificially stimulating inflammation while evading the body’s normal immune defences. I think it is only something which could be done very cautiously – and require a very different ethos. You could not call what we have now an ethos at all: it is more like the witches in Macbeth “Fair is foul, and foul is fair”.

Incidentally, all submissions to the Nuffield consultation were supposed to be posted on the web. Mine did not appear and they denied ever having received it. It did not appear after being re-submitted either. It also points to another bioethicist trick of arguing on the basis of a false scientific premise. Of course, if the scientific premise was true then the conclusion might follow – in this instance it is always the case for forced vaccination – but actually it is just a bureaucratic construction (and often a deeply corrupt one), not science.

It is fortunate at least that the Nuffield consultation’s report stepped back from recommending forced vaccination – after all the great and good would have to have their own children and grandchildren vaccinated. This is probably a different situation from the US and Australia since financial sanctions against non-vaccinators would probably not be politically acceptable here (ie you buy out if you are rich enough).

Here’s some information on HPV vaccination from an Australian layperson’s perspective, which I suggest is relevant to the international situation, including Japan.

In particular, I suggest there should be more critical analysis of the implementation of HPV vaccination in Australia in 2006/2007. In this regard please see the detailed letter I forwarded to Irish Senator Paschal Mooney in November 2015, which includes background on the questionable implementation of Gardasil HPV vaccination in Australia, an action that had a domino effect with the implementation of HPV vaccination around the world. The letter is available via this link: https://elizabethhart.files.wordpress.com/2013/01/letter-to-senator-paschal-mooney-re-hpv-vaccination.pdf

In my letter I include information on the way the Gardasil vaccine was fast-tracked in Australia in 2006/2007, after it was initially knocked back by the Pharmaceutical Benefits Advisory Committee, a decision that was over-turned within 24 hours by the then Australian Prime Minister John Howard, after pressure from senators and vested interests. This occurred in the lead-up to the 2007 Australian Federal election.

This political decision to fast-track HPV vaccination in Australia had massive consequences. I suggest more attention should be paid to the very questionable way this vaccination was implemented in Australia, and subsequently fast-tracked around the world.

Some academics challenged this at the time, i.e. Marion Haas et al and Elizabeth Roughead et al, (as detailed in my letter to Senator Mooney), but this appears to have been suffocated. This matter needs to be resurrected.

Not only did we have questionable implementation of this vaccine in the first place, but subsequently we’ve been inundated by so-called ‘peer-reviewed’ material backing HPV vaccination, safety etc. But how objective is this material? Much of it is associated with industry funding, and with academics who have been involved with HPV vaccination since its inception, e.g. Julia Brotherton, Suzanne Garland and Peter McIntyre in Australia, and Lauri Markowitz (CDC) in the US. It is inappropriate that these people are also reviewing the effectiveness and safety of HPV vaccination. Markowitz is an author of the Cochrane HPV vaccine review – which has not as yet seen the light of day. I followed up on this with Cochrane’s Editor-in-Chief, David Tovey, recently, and it’s still not ready…

The aggressive promotion of the HPV vaccines is astounding, only lip service is paid to any idea of real evaluation of risks and benefits and ‘informed consent’ before this vaccination. At this stage we have no idea of the long-term repercussions of these vaccine products, but how many children and parents know that? Precious few I would wager. The children are guinea pigs and they don’t know this.

In regards to the way the death rate of cervical cancer is promoted, e.g. that cervical cancer kills 250,000 annually, (a figure used by Ian Frazer in his HPV vaccine promotion), I suggest use of this figure is alarmist in countries such as Australia, where the death rate from cervical cancer is low, and has been declining before the implementation of HPV vaccination.

We hear that cervical cancer is more deadly in developing countries. Is it? Where’s the evidence? It’s my understanding the alarming 250,000 figure is an estimate. It’s wrong that ‘estimates’ are being used as fact to sell this vaccine, particularly in countries where this figure is absolutely not relevant, such as Australia.

Also, in regards to cervical cancer being more prevalent in developing countries, it’s ironic that it’s mostly girls and women in developed countries who are getting the jab, see this report on CIDRAP: First estimate of global HPV vaccine uptake finds wide disparities (scroll down this webpage for the article: http://www.cidrap.umn.edu/news-perspective/2016/06/news-scan-jun-21-2016 )

Of course HPV vax is being promoted in developed countries, these are the countries that are being hit for the high cost of this vaccine, around $400 for the three doses in Australia I understand, although there is much secrecy about the cost of vaccines in this country, an expense that is hidden from taxpayers.

Again, I suggest it’s time to revisit the questionable way HPV vaccination was implemented in Australia in 2006/2007 and subsequently around the world, including the vested interests of promoting parties such as academics and the pharmaceutical industry.

Benzo, opioids, SSRI’s, vaccine, drugs who are almost all right on the edge of being illicit on the molecular level. But they are pharmaceutical drugs, we still need them in one shape or form. But right now they aren’t treated with the necessary respect.

We need a system like the “NTSB” (And other air traffic inspectionary agencies)

The “NTSB” is probably not free from corruption, I’m sure Boeing and Airbus spends alot on greasing the inspectors to withhold information. But from the outside their system seems to work.

But their “essence” is what we need, men and women who are almost obsessed with finding the cause, the root cause, in literal seas of debris. Finding such humans are not hard, I believe this page is set up by one. The internet contains many others, from vaccine to opioids, from GMO’s to global warming.

The issue is to get Big Pharma to see the importance of costumer relations, and to stop their blockage of truly unbiased science.

Well, it’s an ‘Utopia’, not very likely to happen, but all of humanity would need it, so we should atleast strive for it?
Ove2016

I can remember the pressure for our children to have the Whooping Cough and other vaccines, and only just managing to get them excluded from the former because they had both had small fits in early babyhood. They never contracted Whooping Cough.

I can also remember chatting with a headmaster during the lunch break when I was running an arts workshop for his primary school. He told me about his young daughter, who had been fine until the day she had her injections. Overnight, she had fever, and she changed. She was brain damaged. No one would listen to him and his wife explaining how they just absolutely KNEW the injection had done this. They were told it would have happened anyway, maybe it was just the way this child had naturally developed. There was no compensation, which might at least have helped the family pay for physical help with round-the-clock care for her. Backs were turned, walls of denial went up, from the medical profession and Government. No boat rocking here please!

As John Stone states, ‘there are institutional directives to stop these real harms being discussed’, or even I feel, admitted.

Another friend of mine has a son who suddenly became ?autistic almost immediately after vaccination. He has had great struggles getting employment, and being treated with respect by his peers. He is a fine person and was a great friend of my son’s, but he has had his life’s chances compromised for the sake of the many. His sister has struggled to get single vaccinations instead of the 3-in-one for her child. I think in Australia you have to have had all three to be accepted for a school place.

Another friend’s daughter did not want to have the cervical cancer vaccine, which was being rolled out routinely at her school. The fight she had over establishing her daughter’s expressed wish and right not to have it, caused great stress.

You can’t have it both ways. If you insist that these vaccines be used on all, then you must admit when they cause damage (even if you scientifically cannot prove causal link – you MUST credit the parents with knowing their own child and reporting linked change, even if you overcompensate in some cases) and expend all possible resources and understanding for anyone badly affected by them. In medicine there seems to be an acceptance of ‘collateral damage’ – a few are sacrificed for the supposed benefit of the majority. We’ve heard it from the mouth of an MHRA representative ourselves in front of MPs, regarding the acne drug RoAccutane/isotretinoin, made by Roche. And then there was the anti-malarial drug Lariam, routinely dished out to the Army, thousands badly affected. Lariam, also made by Roche….

And then, quietly, they hush it up. Of course, it’s Catch 22 isn’t it; if you admit there is any damage at all, then word will get around and the herd will stampede away from the risk and refuse the meds. Maybe we need to go back to the painstaking hand washing, and other kinds of hygiene and behaviour, to avoid the need for quick fix vaccines at all.

having taught for 40 years in primary schools, the final 12 or so years as nursery teacher,special needs co-ordinator and special needs teacher in mainstream primaries, I have lost count of the number of pupils that we came across who had been ‘damaged by vaccines’. The parents could pinpoint the day that things changed for their child and even tell you how many hours that was after the vaccination. The ‘damage’ were mainly in specific language areas all the way up to, and including, autism. The ‘evidence’ was from parents – no-one, psychiatrists, psychologists nor speech and language specialists would accept the reality of the situation. I recall one family where the child concerned was their 8th. You would expect a mum of eight to be on the ball as regards progress suddenly lost and replaced by regression, and she was. She harassed the LEA to have a Statement of Need for her son – and, eventually, got it. All along she was told things like ‘ choosing Welsh-medium education for a child from a non-Welsh speaking family’ had caused the problem. All of her children had been through the school – so that argument didn’t hold water. They also tried to say that ‘he was communicating non-verbally because the older siblings were speaking on his behalf’. That didn’t hold water either as the poor lad couldn’t, and didn’t wish to, give eye-contact never mind any communication. All that he was really expressing was “leave me alone in my little world”. The professionals had to eat their words when, with many hours spent 1 on 1, he became a Welsh speaker and managed fairly well within mainstream classes. We had insisted all along that being in our nursery class would give him a second chance at language acquisition since roughly 1% only of the intake came to school with a command of the Welsh language – and it certainly worked for him. It is disgusting that parents have to suffer like this. It is distressing to see your child falling back rather than making progress, having to fight the system to get their entitlement is soul destroying. It happens at all levels and needs to be fought tooth and nail so that the rights of parents, on behalf of their children, takes priority over the ‘commands of governments’.

Annie, thank you for alerting us to this desperately sad story. We’ve signed up to the petition.

Once again, here we see a death happening and parents being sidelined and kept out of the loop by a GP. The whole ‘family ethic’ is being lost. Everything in our society is being stood on its head. To think that a 16 year old would feel she had to be so ‘strong and grown up’ that she went alone and confidentially to the GP for help with anxiety, and then, even when she overdosed, she spent precious time Googling overdose effects of the beta blocker, and Facebooking her friends for help, when mum and dad were a few steps and seconds away in their bedroom and might have saved her if they’d known in time. Is this what our children’s world has become? These are young people, with so many vulnerabilities, with loving families who care, but their caring is not trendy these days, it’s not cool, it can’t be normal…. Those poor, poor parents, who have nurtured and loved that daughter for 16 years, and now three packets of pills and a thoughtless GP has taken her away for ever. How utterly mad is that.

Fabulous work. I think the job you did of tracking down the pharma sponsored trials which Trial Tracker claimed were undisclosed would be a fantastic “citizen science” task which would get interested members of the public engaged with this issue better than All Trials and Open Trials have done up to now. As you point out, the main undisclosers are from academia not industry. Tracking down conflicts of interest could be another interesting task to crowd source.

Not only has the Chair of the Royal College of General Practitioners completely misled the public by exclaiming in the National Press that ALL GPs are knowledgeable about psychotropic drugs but the MHRA is also totally misleading with claims of ‘Serotonin’ boosting qualities and accordingly not paying attention to the Long Lists of ADRs in the PIL Leaflets?

These Two Complete Errors of Judgement are given to us as if we are born yesterday…?

Bob’s ‘chemical imbalance’ correspondence:

Dear Mr Fiddaman

Apologies for the delay in responding.

Regarding your below enquiry, benefits are considered to be the therapeutic effects of the product to improve the medical conditions for which a product licence has been granted. These are set out as the Therapeutic Indications in the Summary of Product Characteristics (SmPC) and in the uses of the product in the Patient Information Leaflet (PIL). To further understand these benefits, you have asked what positive thing is going to happen to alleviate your depression. The way in which the therapeutic effects are achieved is also explained in these documents. In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression (and the other indications listed). The MHRA does not promote medicines, but agrees in the SmPC a factual summary of the effects of taking a particular medicine based on the results of clinical and non-clinical studies.

I hope this answers your question.

Best regards

The FOI Licensing Team

—

My response…

Thank you for this.

So, in essence you are telling me that, “In the case of fluoxetine, it raises the level of the neurotransmitter, serotonin, in the brain which can improve symptoms of depression.” is the one benefit and that this one benefit has been measured against the risks and the MHRA have granted Prozac a licence because they see that this one benefit outweighs the following reported risks with Prozac use…

Please try and help me (and others) understand how one benefit of a product outweighs the following risks associated with Prozac use.

“Japanese women’s health is increasingly at risk as public-health policy is driven by conspiracy theories, misguided political interference and bureaucratic caution. This is particularly evident in the government’s handling of the human papillomavirus (HPV) vaccine to protect against cervical cancer. In June 2013, just two months after the HPV vaccine was included in the National Immunization Program, the Japanese government made the unusual and perplexing decision to keep the vaccine in the NIP but suspend “proactive” recommendations for it. This was evidently in response to highly publicized accounts of alleged adverse reactions. The result was that girls in the target age group, from the 6th grade of primary school to the third grade of high school, stopped receiving the vaccine. Vaccination rates dropped to below 1% from about 70%…. The Vaccine Adverse Reactions Review Committee, a task force established by the Japanese Ministry of Health, Labor, and Welfare’s Health Science Council, has repeatedly concluded that no causal link exists between HPV vaccines and professed symptoms, and that most reported cases were likely psychosomatic. …”

“These events are reminiscent of the biggest vaccine scandal in history. In 1998, Andrew Wakefield published “scientific data” in the Lancet as evidence that the MMR vaccine for measles, mumps and rubella caused autism. Mr. Wakefield’s data was later found to be manipulated, but it was not until 2010 that his paper was retracted and his medical license revoked. Earlier this year, Mr. Wakefield released a movie called “Vaxxed: From Cover-Up to Catastrophe.” Robert De Niro, whose son is autistic, tried to premiere this movie at the Tribeca Film Festival. This once again fueled antivaccine sentiment in the U.S. We can’t afford to sit back and allow a similar situation to develop in which unscientific claims jeopardize lives around the world. The Japanese government should reinstate its proactive recommendation for the HPV vaccine..”

Very crude stuff. No mention of the fact, of course, that when Wakefield’s data was reviewed by a High Court judge in the case of his senior colleague Prof Walker-Smith it was found to be perfectly in order, but of course it does not tell you anything about HPV vaccine (two completely different products anyway). What links the stories is that with vaccine culture you have to have a vitriolic campaign against anyone who doubts (and like the Sunday Times who went after Wakefield the WSJ is Murdoch owned). You can employ the same same machine and invoke the public good irrespective of the product.